Guardian II and Guardian II NC Hemostasis Valves 의 안전성 경고

Safety alert

2013-03-04

2013-03-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130304.html

Medical device safety alert: vascular solutions guardian ii and guardian ii nc hemostasis valves medical device manufacturer, vascular solutions inc., has issued a medical device safety alert concerning guardian ii and guardian ii nc hemostasis valves. the affected model numbers are fh101, fh101-t, fh101-25, fh101-50, fh102, fh102-t, fh102-25 and fh102-502. there is a low risk that air may be introduced into certain lots of the device, which may lead to an air embolism. due to the potential harm, the manufacturer is recalling the affected products. the root cause of the problem is related to a slight reduction in the outside diameter (still within validated tolerances) of the wiper seal of the device. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 march 2013.